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CQ Roll Call – Cancer Institute Chief Will Lead FDA on Acting Basis

CQ Roll Call – Cancer Institute Chief Will Lead FDA on Acting Basis

Norman E. “Ned” Sharpless, the current head of the National Cancer Institute at the National Institutes of Health, will serve as the acting Food and Drug Administration Commissioner when Scott Gottlieb steps down in April, Health and Human Services Secretary Alex Azar told lawmakers Tuesday.


The administration is still considering who to nominate as the permanent FDA commissioner, Azar told the Energy and Commerce Health Subcommittee during a hearing on the HHS fiscal 2020 budget proposal.


Sharpless has been the NCI director since October 2017. The cancer institute is the largest part of the NIH, accounting for $6.1 billion of the agency’s $39.1 billion budget in fiscal 2019.

Sharpless led the cancer institute as it was engaged in high-profile clinical trials and research partnerships. One of the institute’s priorities has been precision medicine, with one clinical trial that matches patients with a treatment based on genomic sequencing of their tumors. Right before Sharpless started at the cancer institute, the NIH launched a partnership with 11 drugmakers to focus on drugs that harness the immune system to fight cancer cells.


Sharpless is a physician and researcher who previously ran the cancer center at the University of North Carolina, where he also earned his medical degree. He spent most of his career in various roles at the UNC medical school. He also co-founded two companies that focus on early-stage cancer drug research.


As a researcher, Sharpless specialized in the relationship between cancer and aging. In addition to running the NIH’s cancer institute, he ran a lab at the NIH’s National Institute of Aging that studied the aging process in genetically-engineered mice.


Gottlieb announced last week that he would leave the FDA after nearly two years as its leader. The announcement came as a surprise because of many plans launched by Gottlieb that were still under development, including efforts to help speed up the drug development process and efforts to reduce tobacco use.


In a separate statement, Azar said Sharpless had a “deep scientific background and expertise” and said that initiatives started by Gottlieb would continue.


“There will be no let-up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes,” Azar said.


If Sharpless is eventually tapped for the position permanently, he would likely be welcomed by some corners of the health policy world.


“We have no doubt that Dr. Sharpless will continue to navigate and direct the FDA in a manner that best benefits patients,” said Ellen Sigal, director of the Friends of Cancer Research, a nonprofit advocacy group that works closely with the FDA and NIH.


Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said that Sharpless’ experience as a researcher means he “will be able to continue FDA’s work prioritizing the review and approval of innovative therapies that have the potential to cure diseases like cancer.”…